NZ532714A - A hard gelatin or cellulose-based capsule comprising a surface coating including a nonionic surfactant - Google Patents
A hard gelatin or cellulose-based capsule comprising a surface coating including a nonionic surfactantInfo
- Publication number
- NZ532714A NZ532714A NZ532714A NZ53271402A NZ532714A NZ 532714 A NZ532714 A NZ 532714A NZ 532714 A NZ532714 A NZ 532714A NZ 53271402 A NZ53271402 A NZ 53271402A NZ 532714 A NZ532714 A NZ 532714A
- Authority
- NZ
- New Zealand
- Prior art keywords
- sorbitan
- capsule
- nonionic surfactant
- capsule according
- polyoxyethylene
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- General Preparation And Processing Of Foods (AREA)
Abstract
A hard gelatine or cellulose-based capsule including a physiologically acceptable nonionic surfactant coating. The coating provides excellent glide, anti-static properties and printing quality without preventing its degradation.
Description
53 27 U
WO 03/039522 PCT/IB02/04419
Surface Coated Capsules
Field of the Invention The present invention relates to a capsule for medicines or foods.
Background of the Invention There are a wide variety of capsules such as soft capsules prepared by adding glycerin to gelatin, gelatin hard capsules which are essentially composed of gelatin and do not contain glycerin, cellulose-based hard capsules which are essentially composed of a cellulose derivative substrate, and the like. To produce these capsules, the capsules must have suitable glide in order to make the best use of the performance of a machine in inspection,
printing, filling and packing steps. To provide this glide, some surface treatment must be made on the surface of each capsule under the present conditions.
Surface treating agents for the surface of a capsule include magnesium stearate, starches, carnauba, talc and oily application agents such as vegetable oils. In the case of solid powders, it is difficult to control the application amount thereof. Further, in the case of solid powders, there is some fear of the health damage by inhaling scattered powders in the process of the surface treatment.
Since the oily application agents generally have a high dielectric constant and poor conductivity, a capsule coated therewith is readily charged with static electricity. Therefore, when a large number of capsules are handled, for example, they are set in a capsule filling
machine, they may be adhered to a capsule container such as a vinyl bag. The handling of these capsules is inconvenient. Further, when the surface of a capsule is printed with an ordinary capsule printing ink whose solvent is water or alcohol, there is a fault that the ink on the printed surface is readily rubbed off.
Summary of the Invention
The object of the present invention is to provide a surface application agent for capsules, the amount of which is easily controlled, the application of which provides lubricity and an antistatic effect to a capsule and which has affinity for a printing ink whose solvent is water or alcohol, or at least to provide a useful choice. Further, the uses of the capsules can include a use for a medicine, use for a food and a use for a medicine for animals. When it is used for a medicine or a food, the surface application agent must be safe to the human body when consumed.
As a result of a wholehearted investigation in order to solve the above object, the inventors of the present invention have completed the present invention.
The present invention relates to a hard gelatine or cellulose-based capsule whose surface is coated with a nonionic surfactant in a weight of 30 to lOOppm based on the weight of an empty capsule and exhibiting an amount of static electricity of 70V or less as measured on a size 3 capsule.
INTELLECTUAL PROPERTY OFFICE OF N.Z.
2 0 DEC 2006
RECEivp n
Brief Description of the Drawings
Fig. 1 is a graph showing the results of the glide test on capsules.
Fig. 2 is a graph showing the results of the electrostatic property test on capsules.
Detailed Description of the Invention
Physiologically acceptable nonionic surfactants include, for example, cholesterol, sucrose fatty acid ester, stearyl alcohol, polyoxyl stearate 40, sorbitan sesquioleate, cetanol, cetomacrogol 1000, diethyl sebacate, sorbitan trioleate, polyoxyethylene octylphenyl ether, polyoxyethylene hardened castor oil 5, polyoxyethylene hardened castor oil 10, polyoxyethylene hardened castor oil 20, polyoxyethylene hardened castor oil 40, polyoxyethylene hardened castor oil 50, polyoxyethylene hardened castor oil 60, polyoxyethylene hardened castor oil 100,
polyoxyethylene stearyl ether, polyoxyethylene sorbitol beeswax, polyoxyethylene (20) polyoxypropylene (20) glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (120) polyoxypropylene (40) glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polysorbate 20, polysorbate 60, polysorbate 65, polysorbate 80, macrogol 400, sorbitan monooleate, glycerin monostearate, sorbitan monostearate, sorbitan monolaurate, lauryl dimethylamine oxide solution, diethanolamide laurate, lauromacrogol and sorbitan monopalmitate.
The physiologically acceptable nonionic surfactants preferable for the present invention include cholesterol,
polyoxyl stearate 40, sorbitan sesquioleate, cetomacrogol 1000, diethyl sebacate, sorbitan trioleate, polyoxyethylene octylphenyl ether, polyoxyethylene hardened castor oil 5, polyoxyethylene hardened castor oil 10, polyoxyethylene hardened castor oil 20, polyoxyethylene hardened castor oil 40, polyoxyethylene hardened castor oil 50, polyoxyethylene hardened castor oil 60, polyoxyethylene hardened castor oil 100, polyoxyethylene stearyl ether, polyoxyethylene sorbitol beeswax, polyoxyethylene (20) polyoxypropylene (20) glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (120) polyoxypropylene (40)
glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polysorbate 20, polysorbate 60, polysorbate 65, polysorbate 80, macrogol 400, sorbitan monooleate, glycerin monostearate, sorbitan monostearate, sorbitan monolaurate, lauryl dimethylamine oxide solution, diethanolamide laurate, lauromacrogol or sorbitan monopalmitate.
The physiologically acceptable nonionic surfactants more preferable for the present invention include cholesterol, polyoxyl stearate 40, sorbitan sesquioleate, cetomacrogol 1000, sorbitan trioleate, polyoxyethylene hardened castor oil 60, polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polysorbate 20, polysorbate 60, polysorbate 80, macrogol 400, sorbitan monooleate, glycerin monostearate, sorbitan monostearate, sorbitan monolaurate, lauromacrogol or sorbitan monopalmitate.
The nonionic surfactant used in the present invention is preferably insoluble in water and soluble in an alcohol.
The nonionic surfactants which are insoluble in water and soluble in an alcohol include cholesterol, sucrose fatty acid ester, stearyl alcohol, cetanol, cetomacrogol 1000, diethyl sebacate, sorbitan trioleate, polyoxyethylene octylphenyl ether, polyoxyethylene hardened castor oil 5, polyoxyethylene hardened castor oil 10, polyoxyethylene hardened castor oil 20, polyoxyethylene hardened castor oil 40, polyoxyethylene hardened castor oil 50, polyoxyethylene hardened castor oil 60, polyoxyethylene stearyl ether, polysorbate 65, sorbitan monooleate, sorbitan monostearate, sorbitan monolaurate, diethanolamide laurate, lauromacrogol and sorbitan monopalmitate. The preferable nonionic surfactants include cholesterol, sucrose fatty acid ester, stearyl alcohol, cetanol, diethyl sebacate, sorbitan trioleate, polyoxyethylene hardened castor oil 5, polyoxyethylene hardened castor oil 10, polyoxyethylene hardened castor oil 20, polysorbate 65, sorbitan monooleate, sorbitan monostearate, sorbitan monolaurate or sorbitan monopalmitate, more preferably cholesterol,
diethyl sebacate, sorbitan trioleate, polyoxyethylene hardened castor oil 5, polyoxyethylene hardened castor oil 10, polyoxyethylene hardened castor oil 20, polysorbate 65, sorbitan monooleate, sorbitan monostearate, sorbitan monolaurate or sorbitan monopalmitate.
In most of printing inks used in medicines, a shellac that contains an alcohol as a solvent is used as a binder. Alcohol-soluble surfactants have good affinity for these printing inks.
A capsule essentially composed of gelatin or the like commonly swells with water. In comparison, a surfactant, which is insoluble in water, prevents swelling or
deformation of the capsule, reduces friction and provides high lubricity to the capsule.
The nonionic surfactant used in the present invention preferably is a nonionic surfactant having an HLB value of 9 or less.
The nonionic surfactant having an HLB of 9 or less includes sorbitan trioleate (HLB = 1.8), sorbitan monoleate (HLB = 4.3),
sorbitan monostearate (HLB = 4.7), sorbitan monolaurate (HLB = 8.6), cetanol, stearyl alcohol, sucrose fatty acid esters and sorbitan monopalmitate (HLB = 6.7). Preferably the nonionic surfactant includes sorbitan trioleate (HLB = 1.8), sorbitan monooleate (HLB = 4.3), sorbitan monostearate (HLB = 4.7), sorbitan monopalmitate (HLB = 6.7) and sorbitan monolaurate (HLB = 8.6). The most preferred nonionic surfactant in the present invention is sorbitan monolaurate which is liquid at room temperature and does not deteriorate due to rancidity.
The application amount of the nonionic surfactant is 30 to 100 ppm and more preferably 50 to 100 ppm based on the weight of an empty capsule.
To carry out the present invention, the application amount of the nonionic surfactant can be controlled easily by being dissolved in or diluted with a solvent such as ethanol in a suitable ratio and spraying the resulting solution or being impregnated into a sponge and applied to the surface of a capsule in accordance with the conventional method.
IPONZ 26 SEP 2006
Although the effect of the invention is shown below concretely, the examples below do not limit the invention in any way.
Examples
Example 1 Production of capsule and glide test
Commercially available sorbitan monolaurate (SML) was diluted with ethanol (EtOH) of the Japanese Pharmacopoeia in a weight ratio of 9:1 (SML: EtOH) and sprayed over empty hard gelatin capsules so that it adheres to the capsule surface with the amount of 10, 30, 50, 100 and 200 ppm based on the total weight of an empty hard gelatin capsule. After 30 minutes, a predetermined amount of the obtained capsules were placed in a transparent acryl box, followed by opening a shutter on one side of the box so that the capsules could slide out of the box by their own weight and the glide of the capsule was assayed by measuring the height of the capsules from the bottom when the flow of the capsules stopped. The better the glide is, the smaller the height of the capsules becomes. The results are shown in Fig. 1.
As shown in Fig. 1, the glide of the capsule is apparently improved as compared with that of uncoated capsules (the amount of adhesion: 0 ppm) by applying the application agent of the present invention to the outer surface of the capsule.
Electrostatic property test
Empty capsules coated with sorbitan monolaurate in the same manner as in Example 1 were placed in a stainless steel cup, which was then placed on an insulating sheet.
PCT/1B02/04419
The propeller of a stirrer was inserted into the stainless steel cup to stir the capsules at a predetermined revolution speed, and the electrostatic voltage of the capsules at 2 minutes after the start of stirring was measured by an electrostatic meter (SSD STATIRON-M2 of Shishido Electrostatic Ltd.). The results are shown in Fig. 2. It was confirmed that the amount of electrostatic charge was effectively reduced by the application agent of the present invention.
Printing property test 1
After the surface of an empty capsule applied with sorbitan monolaurate in the same manner as in Example 1 was printed with a black ink for medicines which is allowed to be used as a medicine (BLACK P-10 of Saneigen FFI Co., Ltd.), a Rub-off test where a piece of cellophane tape was affixed to and rubbed off from the printed surface was carried out. The results are shown in Table-1.
Table 1
Surface treating agent amount of application (ppm)
result of the Rub-off test
Sorbitan monolaurate
satisfactory, no exfoliation of ink
50
satisfactory, no exfoliation of ink
200
satisfactory, no exfoliation of ink
Even when the application agent of the present invention was applied with 200 ppm based on the weight of an empty capsule, the exfoliation of the ink was not observed.
Printing property test 2
WO 03/CI39522
After the surface of capsules was printed using a black ink and a blue ink for medicines (BLACK P-10 and BLUE B2-30 of Saneigen FFI Co., Ltd.) and a gray ink (Gray S9-27617 of Calcon Co., Ltd.) in the same manner as the printing property test 1, 20,000 capsules for each ink were inspected. The capsules were coated with 30 ppm of sorbitan monolaurate (SML). The printing quality is based on the equivalent inspection standard as that for in-house shipping products by the capsule appearance inspection machine made by the applicant. The results are shown in Table 2.
Table 2
Number of capsules from which ink was exfoliated/number of samples: 20,000 capsules each
Ink
Defect
SML 30ppm
Gray ink
Slightly Unsatisfactory
0
Slightly Defective
0
Black ink
Slightly Unsatisfactory
0
Slightly Defective
0
Blue ink
Slightly Unsatisfactory
0
Slightly Defective
0
As shown in the table, no failure was observed in the capsule of the present invention, the sufficient practicability for the' printing quality has been confirmed.
Claims (9)
1. A hard gelatin or cellulose-based capsule comprising a surface coating including a nonionic surfactant in a weight of 30 to 100 ppm based on the weight of an empty capsule and exhibiting an amount of static electricity of 70V or less as measured on a size 3 capsule.
2. The capsule according to claim 1, wherein said nonionic surfactant is insoluble in water and soluble in an alcohol.
3. The capsule according to claim 1 or claim 2, wherein said nonionic surfactant has an HLB value of 9 or less.
4. The capsule according to any one of claims 1 to 3, wherein the coating weight of the nonionic surfactant is 50 to 100 ppm based on the weight of an empty capsule.
5. The capsule according to any one of claims 1 to 4, wherein said nonionic surfactant is selected from the group consisting of sorbitan trioleate, sorbitan monooleate, sorbitan monostearate, sorbitan monolaurate, stearyl alcohol, cane sugar aliphatic acid ester, sorbitan monopalmitate and mixtures thereof.
6. The capsule according to any one of claims 1 to 4, wherein said nonionic surfactant is selected from the group consisting of sorbitan trioleate, sorbitan monooleate, sorbitan monostearate, sorbitan monolaurate, sorbitan monopalmitate and mixtures thereof.
7. The capsule according to any one of claims 1 to 4, wherein said nonionic surfactant is sorbitan monolaurate. INTELLECTUAL PROPERTY . OFFICE OF N.Z. - 10 - 2 o DEC 2006 DECEIVED!
8. The capsule according to any one of claims 1 to 7 additionally having a printed surface.
9. A capsule according to claim 1 substantially as herein described with reference to any of Examples 1, Figure 1 and Figure 2. - 11 - IPONZ 2 6 SEP 2006
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001344449A JP4031232B2 (en) | 2001-11-09 | 2001-11-09 | New capsule |
| PCT/IB2002/004419 WO2003039522A1 (en) | 2001-11-09 | 2002-10-23 | Surface coated capsules |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| NZ532714A true NZ532714A (en) | 2007-05-31 |
Family
ID=19157974
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NZ532714A NZ532714A (en) | 2001-11-09 | 2002-10-23 | A hard gelatin or cellulose-based capsule comprising a surface coating including a nonionic surfactant |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20030108599A1 (en) |
| EP (1) | EP1448172A1 (en) |
| JP (1) | JP4031232B2 (en) |
| KR (1) | KR100676791B1 (en) |
| CN (1) | CN1585632A (en) |
| BR (1) | BR0213980A (en) |
| CA (1) | CA2466335A1 (en) |
| EA (1) | EA007380B1 (en) |
| MX (1) | MXPA04003605A (en) |
| NZ (1) | NZ532714A (en) |
| PL (1) | PL369657A1 (en) |
| WO (1) | WO2003039522A1 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5801076B2 (en) * | 2010-03-29 | 2015-10-28 | 阪神化成工業株式会社 | Drug container and manufacturing method thereof |
| JP5860480B2 (en) | 2011-01-11 | 2016-02-16 | キャプシュゲル・ベルジウム・エヌ・ヴィ | New hard capsule containing pullulan |
| US8420057B2 (en) | 2011-09-01 | 2013-04-16 | Qualicaps, Inc. | Capsule having broad color spectrum |
| US8435545B2 (en) | 2011-09-01 | 2013-05-07 | Qualicaps, Inc. | Capsule having broad color spectrum |
| CA3059529A1 (en) | 2017-04-14 | 2018-10-18 | Capsugel Belgium Nv | Process for making pullulan |
| CN110678170A (en) | 2017-04-14 | 2020-01-10 | 比利时胶囊公司 | Pullulan polysaccharide capsule |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE1116867B (en) * | 1960-09-07 | 1961-11-09 | Scherer Gmbh R P | Process for the production of a rectal capsule coating |
| CH510440A (en) * | 1963-01-05 | 1971-07-31 | Scherer Gmbh R P | Gelatin capsules coated with polyethylene glycol |
| DE1181863B (en) * | 1963-01-05 | 1964-11-19 | Scherer Gmbh R P | Process for the production of a rectal capsule coating |
| US3333031A (en) * | 1963-06-14 | 1967-07-25 | American Cyanamid Co | Surface dyeing and pigment marking of gelatin capsules |
| US3436452A (en) * | 1966-03-30 | 1969-04-01 | Ncr Co | Treatment of capsules in liquid to inhibit clustering |
| JPS56152739A (en) * | 1980-04-25 | 1981-11-26 | Tanabe Seiyaku Co Ltd | Production of microcapsule |
| JP2765700B2 (en) * | 1986-08-11 | 1998-06-18 | イノベータ・バイオメド・リミテツド | Pharmaceutical composition containing microcapsules |
| IL87710A (en) * | 1987-09-18 | 1992-06-21 | Ciba Geigy Ag | Covered floating retard form for controlled release in gastric juice |
| US5068110A (en) * | 1987-09-29 | 1991-11-26 | Warner-Lambert Company | Stabilization of enteric coated dosage form |
| US4931285A (en) * | 1988-04-28 | 1990-06-05 | Alza Corporation | Aqueous based pharmaceutical coating composition for dosage forms |
| US5258132A (en) * | 1989-11-15 | 1993-11-02 | Lever Brothers Company, Division Of Conopco, Inc. | Wax-encapsulated particles |
| IE61651B1 (en) * | 1990-07-04 | 1994-11-16 | Zambon Spa | Programmed release oral solid pharmaceutical dosage form |
| US5314696A (en) * | 1991-06-27 | 1994-05-24 | Paulos Manley A | Methods for making and administering a blinded oral dosage form and blinded oral dosage form therefor |
| JP3566739B2 (en) * | 1993-09-30 | 2004-09-15 | 三省製薬株式会社 | Stabilization method for skin external preparation |
| SG80553A1 (en) * | 1995-07-20 | 2001-05-22 | Tanabe Seiyaku Co | Pharmaceutical preparation in form of coated capsule releasable at lower part of digestive tract |
| JP3648745B2 (en) * | 1996-11-28 | 2005-05-18 | ダイキン工業株式会社 | Aqueous dispersion and waterproofing agent |
| WO2000050050A1 (en) * | 1999-02-23 | 2000-08-31 | Isis Pharmaceuticals, Inc. | Multiparticulate formulation |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| EP1204699B1 (en) * | 1999-07-22 | 2005-06-08 | Warner-Lambert Company LLC | Pullulan film compositions |
| KR100393920B1 (en) * | 2000-11-28 | 2003-08-06 | 주식회사 서흥캅셀 | Gelatin hard capsule reducing the static electricity and enhancing the lubrication of surface |
| US20060198815A1 (en) * | 2001-03-19 | 2006-09-07 | Praecis Pharmaceuticals, Inc. | Pharmaceutical formulations for sustained release |
| FR2824330A1 (en) * | 2001-05-02 | 2002-11-08 | Degussa Health Nutrition Holdi | IMPROVED SLIDING GELATINES, PROCESSES FOR THEIR PREPARATION, AND APPLICATIONS THEREOF |
| OA12619A (en) * | 2001-06-21 | 2006-06-12 | Pfizer Prod Inc | Self-emulsifying formulations of cholesteryl estertransfer protein inhibitors. |
| JP2003313125A (en) * | 2002-04-24 | 2003-11-06 | Capsugel Japan Inc | Capsule |
-
2001
- 2001-11-09 JP JP2001344449A patent/JP4031232B2/en not_active Expired - Fee Related
-
2002
- 2002-10-23 CA CA002466335A patent/CA2466335A1/en not_active Abandoned
- 2002-10-23 NZ NZ532714A patent/NZ532714A/en unknown
- 2002-10-23 EP EP02775153A patent/EP1448172A1/en not_active Withdrawn
- 2002-10-23 WO PCT/IB2002/004419 patent/WO2003039522A1/en active Application Filing
- 2002-10-23 KR KR1020047006928A patent/KR100676791B1/en not_active IP Right Cessation
- 2002-10-23 CN CNA028222903A patent/CN1585632A/en active Pending
- 2002-10-23 MX MXPA04003605A patent/MXPA04003605A/en not_active Application Discontinuation
- 2002-10-23 BR BR0213980-4A patent/BR0213980A/en not_active IP Right Cessation
- 2002-10-23 PL PL02369657A patent/PL369657A1/en not_active Application Discontinuation
- 2002-10-23 EA EA200400462A patent/EA007380B1/en not_active IP Right Cessation
- 2002-11-05 US US10/288,624 patent/US20030108599A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| JP2003144527A (en) | 2003-05-20 |
| BR0213980A (en) | 2004-08-31 |
| KR100676791B1 (en) | 2007-02-02 |
| KR20050039736A (en) | 2005-04-29 |
| CN1585632A (en) | 2005-02-23 |
| PL369657A1 (en) | 2005-05-02 |
| WO2003039522A1 (en) | 2003-05-15 |
| CA2466335A1 (en) | 2003-05-15 |
| JP4031232B2 (en) | 2008-01-09 |
| MXPA04003605A (en) | 2004-07-27 |
| EA200400462A1 (en) | 2004-10-28 |
| EP1448172A1 (en) | 2004-08-25 |
| EA007380B1 (en) | 2006-10-27 |
| US20030108599A1 (en) | 2003-06-12 |
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Legal Events
| Date | Code | Title | Description |
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| RENW | Renewal (renewal fees accepted) | ||
| PSEA | Patent sealed |